US Market Report for Orthopedic Growth Factor 2017 - MedCore

iData Research
454 Pages - IDR10402
$2,995.00

General Report Contents
• Market Analyses include: Unit Sales, ASPs, Market Value & Growth Trends
• Market Drivers & Limiters for each chapter segment
• Competitive Analysis for each chapter segment
• Section on recent mergers & acquisitions
The U.S. market reacted strongly to public opinion on the backlash of product INFUSE® for its performance. Initially approved for spinal fusion in 2001, INFUSE® was subsequently approved for tibial fractures in 2004, then for dental operations in 2007. Lawsuits have accused Medtronic of hiding side effects and promoting unapproved use. The decline seen in unit sales in 2013 can be attributed to the controversy and lawsuits surrounding the misuse of INFUSE® for unapproved indications in the spine.

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TABLE OF CONTENTS I
LIST OF FIGURES XVII
LIST OF CHARTS XIX
EXECUTIVE SUMMARY 1
U.S. ORTHOPEDIC BIOMATERIALS MARKET OVERVIEW 1
COMPETITIVE ANALYSIS 4
MARKET TRENDS 6
MARKET DEVELOPMENTS 8
PROCEDURE NUMBERS 9
MARKETS INCLUDED 11
KEY REPORT UPDATES 13
VERSION HISTORY 13
RESEARCH METHODOLOGY 14
1.1 RESEARCH SCOPE 14
1.2 IDATA’S 9-STEP METHODOLOGY 14
Step 1: Project Initiation & Team Selection 14
Step 2: Prepare Data Systems and Perform Secondary Research 16
Step 3: Preparation for Interviews & Questionnaire Design 17
Step 4: Performing Primary Research 18
Step 5: Research Analysis: Establishing Baseline Estimates 20
Step 6: Market Forecast and Analysis 21
Step 7: Identify Strategic Opportunities 23
Step 8: Final Review and Market Release 24
Step 9: Customer Feedback and Market Monitoring 25
DISEASE OVERVIEW 26
2.1 BASIC ANATOMY 26
2.1.1 Osteology and Musculoskeletal System 26
2.2 DISEASE PATHOLOGY AND DISORDERS 28
2.2.1 General Diagnostic 28
2.2.2 Osteoporosis 29
2.2.3 Osteoarthritis 29
2.2.4 Indication for Bone Graft Procedure 30
2.2.5 Indication for Cartilage Repair 31
2.2.6 Degenerative Disc Disease 32
2.3 PATIENT DEMOGRAPHICS 34
2.3.1 General Statistics 34
PRODUCT ASSESSMENT 36
3.1 PRODUCT PORTFOLIOS 36
3.1.1 Growth Factors 37
3.1.1.1 Other products 40
3.2 REGULATORY ISSUES AND RECALLS 42
3.2.1 Growth Factors 42
3.3 CLINICAL TRIALS 43
3.3.1 Growth Factors 43
ORTHOPEDIC GROWTH FACTOR MARKET 48
4.1 INTRODUCTION 48
4.1.1 BMP-2 (Medtronic) 49
4.1.2 PDGF-BB (Wright Medical) 49
4.1.3 BMP-7 (Olympus Biomaterials) 50
4.3 MARKET ANALYSIS AND FORECAST 51
4.4 DRIVERS AND LIMITERS 53
4.4.1 Market Drivers 53
4.4.2 Market Limiters 53
4.5 COMPETITIVE MARKET SHARE ANALYSIS 56
ABBREVIATIONS 59
APPENDIX II: COMPANY PRESS RELEASES 61

Chart 1 1: Orthopedic Biomaterials Market by Segment, U.S., 2013 – 2023 3
Chart 1 2: Orthopedic Biomaterials Market Overview, U.S., 2016 & 2023 3
Chart 4 1: Orthopedic Growth Factor Market, U.S., 2013 – 2023 52
Chart 4 2: Leading Competitors, Orthopedic Growth Factor Market, U.S., 2016 58

Figure 1 1: Orthopedic Biomaterials Market Share Ranking by Segment, U.S., 2016 (1 of 2) 4
Figure 1 2: Orthopedic Biomaterials Market Share Ranking by Segment, U.S., 2016 (2 of 2) 4
Figure 1 3: Companies Researched in this Report, U.S., 2016 5
Figure 1 4: Factors Impacting the Orthopedic Biomaterials Market by Segment, U.S. (1 of 2) 6
Figure 1 5: Factors Impacting the Orthopedic Biomaterials Market by Segment, U.S. (2 of 2) 7
Figure 1 6: Recent Events in the Orthopedic Biomaterials Market, U.S., 2013 – 2016 8
Figure 1 7: Orthopedic Biomaterials Markets Covered, U.S., 2016 (1 of 2) 9
Figure 1 8: Orthopedic Biomaterials Markets Covered, U.S., 2016 (2 of 2) 10
Figure 1 9: Orthopedic Biomaterials Markets Covered, U.S., 2016(1 of 3) 11
Figure 3 1: Growth Factors Products by Company 41
Figure 3 2: Class 2 Device Recall INFUSE(R) Bone Graft 42
Figure 3 3: Class 2 Device Recall Stryker Biotech 42
Figure 3 4: A Study of INFUSE Bone Graft (BMP-2) in the Treatment of Tibial Pseudarthrosis in Neurofibromatosis Type 1 43
Figure 3 5: A Prospective Study of Instrumented, Posterolateral Lumbar Fusions (PLF) With OsteoAMP® 43
Figure 3 6: The Clinical Effect of i-FACTOR® Versus Allograft in Non-instrumented Posterolateral Spondylodesis Operation 44
Figure 3 7: Clinical Study of INFUSE® Bone Graft Compared to Autogenous Bone Graft for Vertical Ridge Augmentation 44
Figure 3 8: RCT of AttraX® Putty vs. Autograft in Instrumented Posterolateral Spinal Fusion (AxA) 45
Figure 3 9: Clinical Study of Injectable Ceramics Bone Graft Substitute Containing rhBMP-2 45
Figure 3 10: Prospective Study of Safety and Efficacy of InQu® Bone Graft Extender in Lumbar Interbody Fusion Surgery (Intebody) 46
Figure 3 11: Long-term Safety and Effectiveness of AUGMENT® Bone Graft Compared to Autologous Bone Graft 46
Figure 3 12: rhBMP-2 vs Autologous Bone Grafting for the Treatment of Non-union of the Docking Site in Tibial Bone Transport 47
Figure 3 13: Evaluation of Radiculitis Following Use of Bone Morphogenetic Protein-2 for Interbody Arthrodesis in Spinal Surgery 47
Figure 4 1: Orthopedic Growth Factor Market, U.S., 2013 – 2023 51
Figure 4 2: Drivers and Limiters, Orthopedic Growth Factor Market, U.S., 2016 55
Figure 4 3: Leading Competitors, Orthopedic Growth Factor Market, U.S., 2016 57
Figure 6 1: Press Release Summary 61

Medtronic
Genzyme
DePuy Synthes
Anika Therapeutics
Ferring Pharmaceuticals
Stryker
NuVasive
Bioventus
Zimmer Biomet
Integra LifeSciences
RTI Surgical
Fidia Pharmaceuticals
MTF
Orthofix
Arthrex
AlloSource
Aastrom
Baxter
Harvest Technologies
Wright Medical
Bacterin International
Arteriocyte
Exactech
LifeNet Health
Biocomposites
Alphatec Spine
Celling Biosciences
Globus Medical
Nuo Therapeutics
K2M
*Not all companies are currently active in every segment or sub-report from this suite. For more details contact an iData Research Product Advisor.

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